Device recall
Z-1615-2018: Miriam Capsule Endoscope System. Model MR1100 Product Usage: MiroCam Capsule…
FDA device recall · Class II · IntroMedic Co., Ltd.
Key facts
| Recall number (Z-number) | Z-1615-2018 |
|---|---|
| Recall event | 79830 |
| Product | Miriam Capsule Endoscope System. Model MR1100 Product Usage: MiroCam Capsule Endoscope System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults. |
| Product code | NEZ |
| Recalling firm | IntroMedic Co., Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 8, 2018 |
| 510(k) numbers | K123428 |
| FEI number | 3013489112 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database